Clinical Laboratory Improvement Amendments (CLIA): Application/Certification and Fee Payment

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Application/certification

How to Apply for a CLIA Certificate - Learn from Centers for Medicare & Medicaid Services (CMS) about the CLIA application process.
CLIA lab changes notification summary
- Lab changes that require a CMS-116 form submission within 30 days of change:
  - Lab director changes for all certificate types (except certificate of waiver)
  - Ownership
  - Certificate type
  - Reinstatement or reactivation of certificate
  - Adding a multisite exception, including adding temporary sites
- Lab changes that only require written notification:
  - Laboratory name
  - Lab location physical address change
  - Mailing, billing, or corporate address
  - Tax ID (EIN)
  - Specialty or subspecialty change
  - Total test volume
  - Telephone or fax number
  - Email address and/or opt-in for email notifications
  - Accreditation organization
  - Multisite information change
  - Certificate of waiver lab director
  - Voluntary closure or termination
  - Reinstatement without gap (less than 6 months)
  - Technical supervisor (high complexity testing)
- Acceptable written notification formats:
  - Email dhsdqaclia@dhs.wisconsin.gov (preferred)
  - Letter or fax CMS-116 form
- Written notification must include the following information:
  - Laboratory name
  - CLIA number
  - Name of the laboratory director and/or owner
  - Change and effective date
  - You may send information in a spreadsheet if you are submitting changes for multiple CLIA certificates

Pay CLIA Fees Online - Use the U.S. Department of the Treasury secure site to make fee payments from a bank account (ACH), debit or credit card.